The following data is part of a premarket notification filed by Davol, Inc. with the FDA for Plastic Attachable Dual Port.
Device ID | K912702 |
510k Number | K912702 |
Device Name: | PLASTIC ATTACHABLE DUAL PORT |
Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
Applicant | DAVOL, INC. 5425 WEST AMELIA EARHART DR. Salt Lake City, UT 84116 |
Contact | Ann Martin |
Correspondent | Ann Martin DAVOL, INC. 5425 WEST AMELIA EARHART DR. Salt Lake City, UT 84116 |
Product Code | LJT |
CFR Regulation Number | 880.5965 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-06-19 |
Decision Date | 1991-09-18 |